Kornimate/medical-research-clean huggingface dataset:
the gut microbiota in stress, mood and eating behaviours.

Conditions: Eating Behavior; Stress; Mood

Summary: diet has a considerable influence on microbiota composition and the intake of either prebiotics (microbiota-specific food or probiotics (live microbiota species) has been shown to induce positive effects in both anxiety and depression. at present there are few studies exploring stress-related conditions such as emotional/comfort eating behaviours, particularly in individuals who have experienced early life stress and/or find stress difficult to deal with in regards to gut microbiome composition and subsequent behavioural outcomes. early life stress has been linked to the development of bulimia nervosa and anorexia nervosa in adolescence and adulthood and since the gut microbiota has been proposed as having a causal role in the aetiology and/or maintenance of disordered eating, an empirical question is whether the microbiota may mediate the relation between stress and disordered eating. this is an investigation into the effects of chronic daily consumption of a prebiotic on stress-related eating and mood.

following an initial screening session based on inclusion/exclusion criteria, participants will be randomly allocated into either the treatment or placebo group and provided with three weeks worth of vivinal-gos or maltodextrin in powder form (sachets). there will be four clinical visits as detailed below: 1. training on how to complete food diaries and collect saliva samples for cortisol awakening response measurements 2. cognitive (affective gonogo and emotion recognition task) and biologic measurements (blood,faecal). this also includes a stress inducing task (fake speech task).provided with supplement and invited to next session in three weeks' time. 3. cognitive (affective gonogo and emotion recognition task) and biologic measurements (blood,faecal). this also includes a stress inducing task (fake speech task). 4. (one week after last visit) collection of final faecal sample

Eligibility criteria:
inclusion criteria: * a positive or negative screen for exposure to adverse childhood experiences * a positive or negative screen for stress/emotional related eating behaviours * written informed consent exclusion criteria: * antibiotic, prebiotic or probiotic use in past three months * pre-existing gastrointestinal disorders

Keywords: stress galactooligosaccharide prebiotic early life stress emotional eating gut microbiota short-chain fatty acids serotonin cortisol
korean multicenter registry of epic stent for iliac artery disease: (k-epic registry)

Conditions: Iliac Artery Disease

Summary: * prospective, single-arm, multi-center registry study * a total of 150 subjects with iliac artery disease who meet all inclusion and exclusion criteria will be included. * patients will be followed clinically for 12 months after the procedure. * duplex ultrasound, ct or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months. * presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months. * quality of life by standardized questionnaires (at baseline \& at 1 \& 12 months)


Eligibility criteria:
inclusion criteria: 1. age 19 years of older 2. symptomatic peripheral artery disease: * moderate or severe claudication (rutherford category 2 or 3) * critical limb ischemia (rutherford category 4) 3. iliac artery lesions with stenosis \> 50% 4. abi \<0.9 5. patients with signed informed consent exclusion criteria: 1. acute critical limb ischemia 2. severe critical limb ischemia (rutherford category 5 or 6) 3. known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents 4. in-stent restenosis lesions (restenosis lesions without previously implanted stents are eligible to the enrollment) 5. bypass graft lesions 6. age \> 85 years 7. severe hepatic dysfunction (\> 3 times normal reference values) 8. significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis 9. lvef \< 40% or clinically overt congestive heart failure 10. pregnant women or women with potential childbearing 11. life expectancy \<1 year due to comorbidity 12. untreated proximal inflow disease of aorta or the ipsilateral iliac arteries (more than 50% stenosis or occlusion)

Keywords: peripheral artery disease, iliac artery, nitinol stent, restenosis
gluten-free diet monitoring in urine

Conditions: Celiac Disease

Summary: the purpose of this study is to develope a novel method to determine gluten intake and to check gluten-free diet adherence in celiac patients by detection of gluten immunogenic peptides in urine.

to date, the mainstay of the management of cd is a strict life-long adherence to gluten-free diet (gfd). follow-up monitoring of the improvement of patients on gfd is essential to assess symptomatic recovery and to monitor complications, as well as to assist patients with dietary compliance. however, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available. in this study, we have overcome these challenges and shown the feasibility of measuring gluten immunogenic peptides (gip) in urine samples in healthy and celiac individuals by solid phase extraction and estimating the peptide concentrations with a reader of anti-gip moab immunochromatographic strips (ic-strips).

Eligibility criteria:
inclusion criteria: * celiac patient: childs (\ 16 years) * written informed consent exclusion criteria: * presence of family history of cd * digestive disease symptoms * known medical disease * use of prescription medications and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study * participation in any other studies involving investigational concomitantly or within two weeks prior to entry into the study and during the course of the study
french registry of first-line treatment of acute promyelocytic leukemia

Conditions: Acute Promyelocytic Leukemia

Summary: the registry aims to compare the two first-line available treatment approaches in non-high-risk apl patients aged ≤ 70 years - atra plus chemotherapy and atra plus ato - in terms of practitioner's choice between the two options, clinical effectiveness and cost-effectiveness, long-term outcome, and short- and long-term toxic effects.

* collection of epidemiological data on non-high-risk apl patients aged ≤ 70 years: age and sex distribution, medical history, prognostic factors (time to treatment start, severity of coagulopathy at presentation, performance status...). * documentation of clinical and biologic effectiveness of the two first-line treatment approaches available for non-high-risk apl patients. * documentation of minimal residual disease (mrd). * correlation of clinical outcomes with the chosen therapy. * validation of published prognostic factors and identification of new prognostic factors

Eligibility criteria:
inclusion criteria: * newly-diagnosed apl (either de novo or therapy-related) based on cytologic criteria and confirmed by the presence of the t(15;17) translocation and/or by the detection of the fusion transcript pml/rarα. * non-high-risk apl (white blood count \< 10000/μl at presentation) * age ≤ 70 years exclusion criteria: * relapsed apl * newly-diagnosed high-risk apl (white blood count \> 10000/μl at presentation) * age \> 70 years
study of methicillin-resistant staphylococcus aureus (mrsa) isolated from infected patients in brazil

Conditions: Methicillin Resistant Staphylococcus Aureus

Summary: this project has as general objective to determine if there is any methicillin-resistant staphylococcus aureus (mrsa) strain disseminating in the hospital of belo horizonte. if this is the case, the investigators will determine if this is an international known strain by typing it by pfge and mlst. the detection of meca gene will be performed by pcr. their susceptibility profile to several drugs will also be accessed and it will be possible to compare the response to those drugs commonly in use to that of daptomycin, a new drug available in brazil. it will be screened for reduced susceptibility to vancomycin by macromethod etest (met) in order to search for visa or hetero-visa. also, due to the discussions at the literature about mutations in genes that are said to be responsible for reduced susceptibility to vancomycin, the investigators will sequence these genes in all pfge type strain of this study looking for mutations already described to compare to the screening results.

multidrug resistant and virulent mrsa strains have been disseminating worldwide and few alternatives of treatment for diseases caused by this pathogen are available. in this study, 36 isolates from colonization or different clinical specimens from infected patients of the hospital rizoleta tolentino neves will be analyzed. these results will provide important data for doctors and nurses, such as whether there is any strain dissemination or not in the hospital what could suggest an outbreak. it will be performed molecular typing by pulsed field gel electrophoresis (pfge) and multilocus sequence typing (mlst). the investigators will evaluate the efficiency of several antimicrobials and the frequency of h-visa and visa among the brazilian mrsa. besides, the investigators will verify the presence of mutation in genes that are involved in resistance mechanisms of visa. according to the strains profile present in the hospital, if this is suggested that there is a dissemination of some strain, the health professionals can start a more rigid infection control measures in order to decrease the number of cases of nosocomial infection, decreasing the time of hospitalization of patients and, consequently the cost for the hospital.

Eligibility criteria:
inclusion criteria: * mrsa from infection sites * mrsa from colonization of the patients who already was infected by mrsa during the time of the study exclusion criteria: * mrsa from colonization of a patient who has not infection caused by mrsa

Keywords: mrsa mlst pfge resistance isolated from colonization
exercise and therapeutic exposure

Conditions: PTSD

Summary: the proposed project seeks to demonstrate that a brief bout of aerobic exercise can improve a particular type of therapeutic learning among victimins of interpersonal violence with or without posttraumatic stress disorder (ptsd).

the proposed study has one aim: specific aim: to examine the effects of acute exercise on the consolidation of therapeutic safety learning. it is hypothesized that participants who engage in 30-min of moderate-intensity aerobic exercise following the first session of imaginal exposure will show larger between-session (visit 2 to 3) reductions in heart rate and anxiety during imaginal exposure to trauma narratives compared to participants who engage in light-intensity exercise.

Eligibility criteria:
inclusion criteria: * experience of interpersonal violence * english speaking * medically healthy exclusion criteria: * any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease and as assessed via the physical activity readiness questionnaire (par-q), which probes into participants' history of heart conditions, chest pain, dizziness, loss of consciousness, bone/joint problems, and medication history). participants would not be excluded if they report this condition being "controlled" or "addressed" through medication or lifestyle change, such as regular exercise. * major medical disorders (such as cancer, aids) * psychotic disorders * intellectual disabilities * developmental disorders * active substance use disorders * pregnancy or probably pregnancy * body mass index greater than or equal to 35 * daily cannabis use * history of any cardiac disease * inability to provide informed consent * physical disabilities that prohibit task performance (such as deafness or blindness) * self-reported history of loss of consciousness (greater than 30 minutes)

Keywords: trauma exercise mental health aerobic
vidas® nephroclear diagnostic accuracy study

Conditions: Acute Kidney Injury; Stage 2 Acute Kidney Injury; Stage 3 Acute Kidney Injury

Summary: this is a multi-center sample analysis study in which urine samples previously collected from persons with stage 2 or stage 3 acute kidney injury (aki), will be tested in order to validate the vidas® nephroclear™ ccl14 test

the vidas® nephroclear™ ccl14 test is intended to be used in conjunction with clinical evaluation, in icu patients with moderate to severe (stage 2 or 3) acute kidney injury (aki), as an aid in the risk assessment for developing persistent severe aki (stage 3 aki lasting ≥ 72 hours) within 48 hours of patient assessment. the vidas® nephroclear™ ccl14 test is intended to be used in patients 21 years of age or older. the objective of this study is to evaluate the diagnostic accuracy of the vidas® nephroclear™ ccl14 test when used on the vidas® 3 instrument. sensitivity, specificity, negative predictive value (npv), positive predictive value (ppv), likelihood ratios (lr), and relative risk (rr), will be evaluated at the pre-determined cut-off values. previously collected urine samples from persons with stage 2 to stage 3 aki will be tested in this study. the vidas® test results will be compared to the clinical aki status established by independent adjudication by medical professionals, that are blinded to the vidas® test results.

Eligibility criteria:
inclusion criteria: * males and females 21 years of age or older; * receiving care in an intensive care unit; * expected to remain in the icu for at least 48 hours after enrollment; * use of indwelling urinary catheter as standard care at the time of enrollment; * subject must have acute kidney injury (kdigo stage 2 or stage 3) at the time of sample collection; * urine sample must be collected within 36 hours of meeting kdigo stage 2 criteria; * documented informed consent provided by patient or legally authorized representative (lar). exclusion criteria: * prior kidney transplantation; * comfort-measures-only status; * already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment; * known infection with human immunodeficiency virus (hiv) or active hepatitis (acute or chronic); (note: hiv or hepatitis testing need not be performed for enrollment in this study.) * special populations, pregnant women, prisoners or institutionalized individuals;
trial of levomilnacipran in geriatric depression

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to examine the effects of levomilnacipran (fetzima) compared to placebo for the treatment of depression in older adults.

a 12-week pilot double-blind comparison of levomilnacipran (fetzima) to placebo for the treatment of geriatric depression. the investigators are interested in assessing the efficacy of levomilnacipran (lmil) to placebo (pbo), and exploring the effects of antidepressant response on brain connectivity and neuroplasticity. this pilot study is designed to determine any differences in the efficacy, safety and tolerability of levomilnacipran compared to placebo, and to perform dose finding (20-120 mg per day) in 40 older depressed adults. the investigators anticipate that the lmil will be superior to pbo in improving levels of depressive symptoms and rates of remission, as well as improving cognition, apathy, and quality of life. this proposal expands the investigator's focus on the biomarkers of neuroplasticity that have been used in several prior studies and demonstrated responsivity to antidepressant treatment. the purpose is to examine this directly in 40 older adults with major depression. this proposed trial will also serve as a pilot study to estimate the efficacy and tolerability of the drug in older depressed adults, and the dose-finding in this population.

Eligibility criteria:
inclusion criteria: * 60 years of age or older * the presence of a major depressive disorder diagnosed according to the diagnostic and statistical manual and mental disorders, 5th edition (dsm-v) criteria * a 24-item hamilton rating scale for depression (hamd) score of 16 or higher at baseline * mini-mental state exam (mmse) score \> 24. exclusion criteria: subjects will be excluded if they had 1) any current and/or lifetime history of other psychiatric disorders (except unipolar depression with or without comorbid generalized anxiety disorder), or 2) recent unstable medical or neurological disorders; 3) any disabilities preventing participation in the study or in the mri; 4) diagnosis of dementia; 5) acute suicidality; 6) subjects with known allergic reactions to milnacipran, uncontrolled narrow angle glaucoma, seizures, poorly-controlled hypertension or ischemic changes on ecg, serotonin syndrome, or the recently used monoamine oxidase inhibitors (maois) within last 4 weeks; 7) ineligible for mri (e.g., metal in the body or claustrophobia)

Keywords: depressed older adults antidepressants depression mdd
multi-center study to assess the efficacy and safety of pt003, pt005, and pt001 in subjects with moderate to very severe copd (pinnacle 2)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of glycopyrrolate (gp and formoterol fumarate (ff) combination metered-dose inhaler (mdi) (gff; pt003), gp mdi (pt001), and ff mdi (pt005) compared with placebo mdi in subjects with moderate to very severe copd.


Eligibility criteria:
key inclusion criteria: * male or female subjects at least 40 years of age and no older than 80 at visit 1. * subjects with an established clinical history of copd as defined by the american thoracic society (ats)/european respiratory society (ers) * current or former smokers with a history of at least 10 pack-years of cigarette smoking. * subjects with fev1/fvc ratio of \<0.70 and fev1 \<80% predicted normal and ≥750 ml if fev1 \<30% of predicted normal value. * subjects willing and, in the opinion of the investigator, able to adjust current copd therapy as required by the protocol key exclusion criteria: * significant diseases other than copd, i.e. disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study * current diagnosis of asthma or alpha-1 antitrypsin deficiency * other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea * hospitalized due to poorly controlled copd within 3 months prior to screening or during the screening period * poorly controlled copd, defined as acute worsening of copd that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the screening period * lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the screening period * unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment. * recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months * congestive heart failure (chf nyha class iii/iv) * clinically significant abnormal 12-lead ecg * abnormal liver function tests defined as ast, alt, or total bilirubin ≥ 1.5 times upper limit of normal at visit 1 and on repeat testing * cancer not in complete remission for at least five years * history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the mdi other protocol-defined inclusion/exclusion criteria may apply
neuromuscular electrical stimulation (nmes) treatment technique therapy in the management of young infants with severe dysphagia

Conditions: Dysphagia

Summary: the goal of this study is to obtain data that well help inform the feasibility and design of a randomized control trial of the therapeutic neuromuscular electrical stimulation (nmes) technique in improving the swallowing function of young infants presenting with severe dysphagia.

infants with severe neurologic disability often have difficulty in eating by mouth due to a disruption in the swallowing process. this swallowing dysfunction, also known as dysphagia, is often evident early in life and when severe can be permanent. dysphagia can lead to an inability to take in enough food to maintain an adequate weight and result in malnutrition. it also can result in food going into the lungs instead of the stomach, resulting in an illness called aspiration pneumonia. both of these complications may require feeding by tube either through the nose into the stomach or directly into the stomach via the abdominal wall, to bypass the swallowing process. this process is resource intense, can be associated with a number of complications and may result in a reduced quality of life for both the infant and caregivers. currently, there are no effective treatments to change the natural course of dysphagia in this context.

Eligibility criteria:
inclusion criteria: * infants with severe dysphagia on vffs as defined by dysphagia resulting in aspiration with swallow of at least 2 food textures (e.g. thin and thick liquid). * we will include children with dysphagia due to a central neurologic deficit. the neurologic diagnosis will be based on the diagnosis from the treating physician. exclusion criteria: * infants with a known or suspected neurodegenerative or peripheral neuromuscular condition or a medical condition that is a contraindication for nmes treatment (tumours in the neck region and neck soft tissue infections). * children with neurodegenerative disorders have been excluded as their natural history of dysphagia would be different from those with a static neurologic disorder.

Keywords: pediatrics dysphagia
global postural re-education and neck isometric exercises in cervical radiculopathy radiculopathy

Conditions: Cervical Radiculopathy

Summary: cervical radiculopathy is a common neurological disorder that is caused by compression of the nerve, inflammation of nerve roots, or space-occupying lesions. cervical radiculopathy is the most common health-related problem worldwide. the conservative approach like education, specific exercises, and spinal manipulation is usually given for chronic cases with good outcomes.

cervical radiculopathy is a condition in which a nerve is entrapped between the bones and causes numbness and tingling. neck isometric exercises are a basic treatment plan for strength training. global postural reeducation is a technique the manual cervical traction along with body alignment that helps to reduce symptoms more rapidly. this whole procedure is completed more easily, without a machine and satisfying for the patient.

Eligibility criteria:
inclusion criteria: 1. 18 to 35 years. 2. both genders, males and females 3. one-sided upper limb pain or numbness 4. any 2 out of 4 tests are positive spurling test, distraction test, ipsilateral cervical traction test, and upper limb test exclusion criteria: 1. bilateral upper limb pain 2. previous history of cervical surgery 3. cervical spine 4. injection therapy in the past 2 weeks 5. being pregnant women